The following is from Celegene’s (maker of Thalidomide and Revlimid) web site:
REVLIMID(R) PDUFA Date Extended Three Months By FDA
SUMMIT, N.J., Oct. 3 /PRNewswire-FirstCall/ — Celgene Corporation (Nasdaq: CELG) announced today that they received notification late Friday from the United States Food and Drug Administration (FDA) that the action date for FDA’s priority review of the New Drug Application (NDA) for REVLIMID (lenalidomide), for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, has been extended to January 7, 2006. The original action date under the Prescription Drug User Fee Act (PDUFA) for the REVLIMID NDA was October 7, 2005.
The extension is a result of the FDA requiring more time to review additional information on Celgene’s RevAssist(R) risk-management program. This additional material has been considered by the FDA to be a major amendment to the REVLIMID NDA allowing the extension of the action date under PDUFA regulations.
“We are working closely with the FDA to enable completion of their review as quickly as possible for REVLIMID approval” said Sol Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation. “We will be ready for immediate commercial launch upon FDA action, and expect a November submission of our REVLIMID application for treatment of previously-treated patients with relapsed or refractory multiple myeloma.”
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